Newsletter

ISO 9001:2015, 7.5

Mar 12, 2015 in Newsletter | Comments Off on ISO 9001:2015, 7.5

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), and clause 6 (Planning for the Quality Management System). Clause 7, Support, has five sub-clauses (shown below). This article is on 7.5 Documented Information. 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.5 Documented Information has the following sub-clauses: 7.5.1 General 7.5.2 Creating and Updating 7.5.3 Control of...

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Audit at the Beach?

Mar 12, 2015 in Newsletter | Comments Off on Audit at the Beach?

If you’ve been contemplating a job change, maybe a life of training, consulting, and auditing at your favorite beach would be of interest. See the description below extracted from the ISO.org web site. Whether it is the soft white sand, or the call of the sea, beaches have an amazing ability to attract people from far and wide. Now they are even easier to keep beautiful with the publication of the first International Standard for beaches. Beaches are not just for sun-seeking tourists. Beaches are important to our ecology, and keeping...

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ISO/DIS 9001:2015, 6.1

Feb 1, 2015 in Newsletter | Comments Off on ISO/DIS 9001:2015, 6.1

Clause 6 of ISO/DIS 9001:2015 has three sub-clauses: 6. Planning for the Quality Management System 6.1 Actions to Address Risks and Opportunities 6.2 Quality Objectives and Planning to Achieve Them 6.3 Planning of Changes This article summarizes the ISO/DIS 9001:2015 requirements in Clause 6.1 and highlights the changes from ISO 9001:2008. Other articles in this newsletter describe clauses 6.2 and 6.3. 6.1 Actions to Address Risks and Opportunities 6.1.1 When planning for the quality management system, consider issues referenced in clause 4.1,...

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ISO/DIS 9001:2015, 6.2

Feb 1, 2015 in Newsletter | Comments Off on ISO/DIS 9001:2015, 6.2

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 6.2 and highlights the changes from ISO 9001:2008. 6.2 Quality Objectives and Planning to Achieve Them 6.2.1 Establish quality objectives at relevant functions, levels, and processes. The quality objectives must be: consistent with the quality policy; measurable; based on applicable requirements; relevant to conformity of products and services and enhancement of customer satisfaction; monitored; communicated; updated as appropriate. Retain documented information on the...

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ISO/DIS 9001:2015, 6.3

Feb 1, 2015 in Newsletter | Comments Off on ISO/DIS 9001:2015, 6.3

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 6.3 and highlights the changes from ISO 9001:2008. 6.3 Planning of Changes Where the organization determines the need for change to the quality management system (see 4.4) the change must be carried out in a planned and systematic manner. Consider the: purpose of the change and any of its potential consequences; integrity of the quality management system; availability of resources; allocation or reallocation of responsibilities and authorities. Changes: This clause...

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Requirements Definition

Feb 1, 2015 in Newsletter | Comments Off on Requirements Definition

Annex SL of the ISO Directives, Part 1 describes the clause structure, core text, and common terminology for all new or changed ISO management system standards. Annex SL defines the term Requirement as the: “need or expectation that is stated, generally implied, or obligatory.” Note 1 of the definition says that “generally implied” means that it is custom or common practice for the organization and interested parties that the need or expectation under consideration is implied. Note 2 of the definition says that a...

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Information Security

Feb 1, 2015 in Newsletter | Comments Off on Information Security

According to the Global State of Information Security® Survey 2015, the number of reported security incidents increased by 48% in 2014. Employees were the most cited culprits of these incidents. Surprisingly, information security budgets decreased slightly in 2014, and declines were also reported in fundamental security practices. The survey was a worldwide study by PricewaterhouseCoopers (PwC), Chief Information Officer (CIO) magazine, and Chief Security Officer (CSO) magazine. The results were based on the responses of more than 9,700 CEOs,...

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Keep Data Safe

Feb 1, 2015 in Newsletter | Comments Off on Keep Data Safe

An organization’s data is often its most valuable asset. Keeping it stored safely and effectively is increasingly a commercial and legal imperative. However, the process of managing it can be complex, covering not only how it is stored, but how to access it securely and communicate it across a wide range of media and devices. Securely storing and protecting data requires a lot more than a simple back up. A new standard for data storage security ensures your valuable information stays in safe hands. ISO 27040:2015 Information technology...

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Outsourcing Standard

Feb 1, 2015 in Newsletter | Comments Off on Outsourcing Standard

Outsourcing, the transfer of work to an external company, is nothing new. But recent years have seen a large increase in this practice and the trend is expected to continue. Behind this pattern are companies choosing to focus on their core business areas and reduce costs. Although the premise of outsourcing can be beneficial, the introduction of an external third party can also backfire and result in lower quality, more complicated interactions, slower turnaround times, and unhappy customers and employees. However, a new ISO standard has been...

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ISO 9001:2015, 5.1

Jan 4, 2015 in Newsletter | Comments Off on ISO 9001:2015, 5.1

ISO/DIS 9001:2015, in 3.05, defines Top Management as the person or group of people who directs and controls an organization at the highest level (for the scope of the quality management system). Clause 5 of ISO/DIS 9001:2015 has three sub-clauses: 5. Leadership 5.1 Leadership and Commitment 5.2 Quality Policy 5.3 Organizational Roles, Responsibilities, and Authorities This article summarizes the ISO/DIS 9001:2015 requirements in Clause 5.1 and highlights the changes from ISO 9001:2008. Other articles in this newsletter describe clauses 5.2...

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ISO 9001:2015, 5.2

Jan 4, 2015 in Newsletter | Comments Off on ISO 9001:2015, 5.2

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 5.2 and highlights the changes from ISO 9001:2008. 5.2 Quality Policy 5.2.1 Top management must establish, review, and maintain a quality policy that: is appropriate to the purpose and context of the organization; provides a framework for setting and reviewing quality objectives; includes a commitment to satisfy applicable requirements; includes a commitment to continual improvement of system. 5.2.2 The quality policy must be: available as documented...

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ISO 9001:2015, 5.3

Jan 4, 2015 in Newsletter | Comments Off on ISO 9001:2015, 5.3

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 5.3 and highlights the changes from ISO 9001:2008. 5.3 Organizational Roles, Responsibilities, and Authorities Top management must ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization. Assign the responsibility and authority to: ensure that the system conforms to the requirements of ISO 9001; ensure that the processes are delivering their intended outputs; report on the performance of the...

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ISO 90003:2014

Jan 4, 2015 in Newsletter | Comments Off on ISO 90003:2014

ISO 90003:2014, “Software engineering – Guidelines for the application of ISO 9001:2008 to computer software” has been published. It provides guidance for organizations in the application of ISO 9001:2008 to the acquisition, supply, development, operation, and maintenance of computer software and related support services. ISO 90003:2014 does not add to or otherwise change the requirements of ISO 9001:2008. The guidelines provided in ISO 90003:2014 are not intended to be used as assessment criteria in quality management system...

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ISO/CD 37001

Jan 4, 2015 in Newsletter | Comments Off on ISO/CD 37001

A committee draft of ISO 37001, “Anti-bribery management systems”, is available. According to World Bank estimates, more than 1 trillion dollars (or 3 % of the world GDP) is paid annually in bribes. In many cases, it is tolerated as a necessary part of “getting business done” or “circumventing bureaucratic red tape”. According to an international study, 27 % of the 3,000 business people surveyed reported that they had lost business due to bribery by their competitors. The damage caused by bribery to...

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Audit Conference

Jan 4, 2015 in Newsletter | Comments Off on Audit Conference

Mark down October 29-30, 2015 on your calendar for the annual ASQ Audit Conference. The theme for the 2015 conference will be “Audits: Improving Performance, Managing Risk, Driving Customer Satisfaction and Revenue”. The conference will be held at the Peppermill Resort, Spa, and Casino in Reno, Nevada. Conference Overview: To achieve effective results, auditors are expected to influence managerial decision making with their audit findings. This conference focuses on the auditor’s role in identifying quality system issues to...

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Energy Management

Jan 4, 2015 in Newsletter | Comments Off on Energy Management

An “Energy Management” article in our December 2014 newsletter described the ISO 50000 series of energy management standards and provided an overview of: ISO 50001:2011, Energy management systems – Requirements with guidance for use ISO 50002:2014, Energy audits – Requirements with guidance for use ISO 50003:2014, Energy management systems – Requirements for bodies providing audit and certification of energy management systems The article mentioned three other energy management standards that would soon be...

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Whittington Speaks on ISO 9001:2015

Dec 1, 2014 in Newsletter | Comments Off on Whittington Speaks on ISO 9001:2015

ISO 9001:2015 – Plan for the Changes Presented by Larry Whittington ASQ Atlanta Dinner Meeting Thursday, January 22, 2015 The new edition of ISO 9001 is coming and will be a major revision of the current standard. Are you aware of the significant changes? Will your organization be ready to successfully make the transition? Larry Whittington will be the presenter. He has trained, consulted, and audited on all four of the ISO 9001 editions (1987, 1994, 2000, and 2008) and will guide us on how to prepare for the 2015 edition. Presentation...

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ISO 9001 to FDIS

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001 to FDIS

The ISO 9001 Draft International Standard (DIS) was recently put to a vote according to ISO procedures and received nearly 90% approval, which allows it to progress to the Final Draft International Standard (FDIS) stage. Experts in the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward for voting. Once approved, the standard can then be published. The new fifth edition of ISO 9001 is expected by the end of 2015 and will...

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ISO 9001:2015, 4.1

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.1

The first requirements clause of ISO/DIS 9001:2015, clause 4, Context of the Organization, has four sub-clauses: 4. Context of the Organization 4.1 Understanding the Organization and its Context 4.2 Understanding the Needs and Expectations of Interested Parties 4.3 Determining the Scope of the Quality Management System 4.4 Quality Management System and its Processes This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.1 and highlights the changes from ISO 9001:2008. The other articles in this newsletter describe clauses 4.2,...

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ISO 9001:2015, 4.2

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.2

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.2 and highlights the changes from ISO 9001:2008. 4.2 Understanding the Needs and Expectations of Interested Parties Due to their impact, or potential impact, on your ability to consistently provide products and services that meet customer and applicable legal requirements, determine: Interested parties that are relevant to system Relevant requirements of these interested parties Monitor and review information about these interested parties and their relevant...

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ISO 9001:2015, 4.3

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.3

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.3 and highlights the changes from ISO 9001:2008. 4.3 Determining the Scope of the Quality Management System Determine the boundaries and applicability of the system to establish its scope. When determining the scope, consider: External and internal issues (see 4.1) Requirements of interested parties (see 4.2) Products and services of organization Apply the requirements of ISO 9001 when they can be applied within the scope. If an organization can’t apply a...

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ISO 9001:2015, 4.4

Dec 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 4.4

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 4.4 and highlights the changes from ISO 9001:2008. 4.4 Quality Management System and its Processes Establish, implement, maintain, and continually improve the quality management system, including the processes needed and their interactions, per ISO 9001 requirements. Determine the processes needed for the system and their application throughout the organization. Determine for these processes the: Inputs required and outputs expected; Sequence and interaction; Criteria and...

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Energy Management

Dec 1, 2014 in Newsletter | Comments Off on Energy Management

An effective energy management system is an essential business ingredient. Are you aware of the ISO standards for energy management systems? ISO 50001:2011, Energy management systems — Requirements with guidance for use ISO 50001 specifies the requirements for establishing, implementing, maintaining, and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy use and consumption. The...

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ISO 9001:2015, 0.6

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 0.6

Clause 0.6 in the Introduction section of the draft ISO 9001:2015 standard is titled, “Compatibility with other Management System Standards.”  It notes that ISO 9001:2015 has adopted the new high-level structure developed by ISO to improve the alignment of its management system standards. The high-level structure is defined in Annex SL of the ISO Directives and provides common: Clause sequence Text Terminology The ISO 9001:2015 requirements are defined in an order that is consistent with organizational planning and process...

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ISO 9001:2015, 1

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 1

Clause 1.1, General, in the Scope section of ISO 9001:2008 has been slightly reworded in clause 1, Scope, of the draft ISO 9001:2015 standard. The term “product” has been expanded to include “service”. Otherwise, the Scope section continues to state that the ISO 9001 standard specifies requirements for a quality management system where an organization: Needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements Aims to enhance...

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ISO 9001:2015, 10.1

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.1

ISO/DIS 9001:2015, clause 10, Improvement, has three sub-clauses: 10.1 General 10.2 Nonconformity and Corrective Action 10.3 Continual Improvement This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.1, General, and also identifies changes from ISO 9001:2008. Other articles in this newsletter describe the requirements in clauses 10.2 and 10.3. 10.1 General The organization must determine and select opportunities for improvement and implement the necessary actions to meet customer requirements and enhance customer...

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ISO 9001:2015, 10.2

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.2

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.2, Nonconformity and Corrective Action, and also identifies the changes from ISO 9001:2008. 10.2 Nonconformity and Corrective Action 10.2.1 When a nonconformity occurs, including those arising from complaints, the organization must react to the nonconformity, and as applicable, take action to control and correct it, as well as, deal with the consequences. In addition, the organization must evaluate the need for action to eliminate the causes of the nonconformity...

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ISO 9001:2015, 10.3

Nov 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 10.3

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.3, Continual Improvement, and also identifies the changes from ISO 9001:2008. 10.3 Continual Improvement The organization must continually improve the suitability, adequacy, and effectiveness of the quality management system. Consider the outputs of analysis and evaluation and the outputs of management review to confirm if there are areas of underperformance or opportunities that must be addressed as part of continual improvement. Where applicable, select and...

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ISO Certificate Survey

Nov 1, 2014 in Newsletter | Comments Off on ISO Certificate Survey

ISO has released the results of its annual survey of certifications. The summary below shows the number of worldwide certificates issued for seven of the management system standards, along with the USA totals. ISO 9001 (Quality) Certificates in 2013 = 1,129,446 (USA = 34,869) Certificates in 2012 = 1,096,987 (USA = 26,177) Increase = +32,459 (USA = +8,692) Percentage = +3% (USA = +33%) ISO 14001 (Environment) Certificates in 2013 = 301,647 (USA = 6,071) Certificates in 2012 = 284,654 (USA = 5,699) Increase = +16,993 (USA = +372) Percentage =...

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ISO/DIS 14001:2015

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015

The current ISO 14001:2004 environmental management standard is being revised after more than a decade of use. The draft ISO 14001:2015 standard has adopted Annex SL of the ISO Directives and will have the same clause structure as the draft ISO 9001:2015 standard. In addition to providing the clause framework for all management system standards, Annex SL also provides common definitions and, where applicable, common text for the requirements. The ISO/DIS 14001:2015 additions to the common Annex SL text are described in the following articles...

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ISO/DIS 14001:2015, Clause 4

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 4

4. Context of the Organization 4.1 Understanding the Organization and its Context ISO/DIS 14001:2015 adds to the common Annex SL text that the issues to be determined include environmental conditions that are capable of affecting or being affected by the organization. According to Annex A of ISO/DIS 14001:2015, these conditions may include climate, air quality, water quality, land use, existing contamination, natural resource availability, and biodiversity. 4.2 Understanding the Needs and Expectations of Interested Parties The draft 14001:2015...

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ISO/DIS 14001:2015, Clause 5

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 5

5. Leadership 5.1 Leadership and Commitment The draft ISO 14001:2015 standard adds another way that top management must demonstrate its leadership and commitment – by taking accountability for the effectiveness of the environmental management system. 5.2 Environmental Policy The policy commitment to meet requirements has been clarified as conforming to compliance obligations. The commitment for continual improvement has been clarified as improving the environmental management system to enhance environmental performance. A third policy...

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ISO/DIS 14001:2015, Clause 6

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 6

6 Planning 6.1 Actions to Address Risk Associated with Threats and Opportunities ISO/DIS 14001:2015 split this clause into five sub-clauses: 6.1.1 General The draft ISO 14001:2015 standard adds that the organization is to plan and implement a process to meet the requirements in clause 6.1. Documented information is to be maintained to the extent necessary to have confidence that the process has been carried out as planned. 6.1.2 Significant Environmental Aspects The draft standard adds that the organization must identify the environmental...

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ISO/DIS 14001:2015, Clause 7

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 7

7 Support 7.1 Resources No additions to the Annex SL text for resources. 7.2 Competence No additions to the Annex SL text for competence. 7.3 Awareness The only ISO/DIS 14001:2015 addition to this clause is that persons doing work under the organization’s control must be aware of the significant environmental aspects and related actual or potential impacts associated with their work. These persons must also be aware of the implications of not conforming with the environmental management system requirements, including compliance...

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ISO/DIS 14001:2015, Clause 8

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 8

8 Operation 8.1 Operational Planning and Control The draft ISO 14001:2015 standard clarifies that operational controls are implemented to prevent deviation from the environmental policy and objectives, as well as, compliance obligations. It also states that the type and degree of control or influence of any outsourced processes must be defined within the environmental management system. The concept of “life cycle perspective” is added that requires the organization to: a) determine environmental requirements for the procurement of...

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ISO/DIS 14001:2015, Clause 9

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 9

9 Performance Evaluation 9.1 Monitoring, Measurement, Analysis, and Evaluation 9.1.1 General The draft ISO 14001:2015 standard adds to the Annex SL text that what needs to be monitored and measured must be related to operations (that can have a significant environmental impact), compliance obligations, operational controls, and progress towards meeting environmental objectives (using indicators). The current ISO 14001:2004 standard does not explicitly require the use of indicators, although their use is widespread. Now it is a clear...

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ISO/DIS 14001:2015, Clause 10

Oct 7, 2014 in Newsletter | Comments Off on ISO/DIS 14001:2015, Clause 10

10. Improvement 10.1 Nonconformity and Corrective Action The common Annex SL text for this clause has been expanded by ISO/DIS 14001:2015 to react to a nonconformity with “immediate” action to control and correct it, as well as, to mitigate adverse environmental impacts. It also adds that corrective actions must be appropriate to the “significance” of the effects of the nonconformity, including the environmental impact. 10.2 Continual Improvement ISO/DIS 14001:2015 clarifies that the reason for continually improving...

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Internet Vulnerability

Oct 1, 2014 in Newsletter | Comments Off on Internet Vulnerability

What is Heartbleed? The Heartbleed vulnerability is a bug in OpenSSL, a popular open-source protocol used extensively on the Internet, which allows anyone who knows how to exploit the vulnerability to access and read the memory of systems thought to be protected. Vulnerable versions of OpenSSL allow compromise of secret keys, user names, passwords, and even actual content. Many security experts believe that this vulnerability has actually existed for at least two years and might have been exploited for just as long. Although many companies...

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ISO/DIS 9001:2015, Clause 0.1

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.1

The General section (clause 0.1) of the Introduction to the ISO 9001:2015 draft standard can be summarized as: Adoption of a quality management system is a strategic decision A robust quality management system can improve performance Its design and implementation is influenced by the context of the organization Specific objectives and associated risks Needs and expectations of customers Products and services Process complexity and interactions Competence of employees Size and organizational structure Culture and socio-economic...

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ISO/DIS 9001:2015, Clause 0.2

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.2

A new sub-clause, “The ISO Standards for Quality Management” has been added to the Introduction to the ISO 9001:2015 draft standard. It provides an overview of the three core quality management system standards: ISO 9000 – Fundamentals and Vocabulary Essential background for understanding ISO 9001 Key terms and their definitions Quality Management Principles (QMPs) The quality management principles form the foundation of ISO 9001. An outline of the QMPs is provided in ISO 9001 Annex B. ISO 9001 –...

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ISO/DIS 9001:2015, Clause 0.3

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.3

ISO 9001:2008 states that it promotes the adoption of a process approach, but it seems to be more an encouragement than a requirement. Clause 0.3 of the draft ISO 9001:2015 standard now refers to specific requirements that are essential for a process approach. Process Approach Consistent and predictable results are achieved more effectively and efficiently when: Activities are understood Managed as interrelated processes Function as a coherent system ISO 9001 promotes use of the process approach to develop, implement, and improve the...

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ISO/DIS 9001:2015, Clause 0.4

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.4

ISO 9001:2008 only mentions the PDCA cycle in a Note within clause 0.2 on the Process Approach.  The draft ISO 9001:2015 standard gives PDCA its very own section. Clause 0.4 states that the PDCA methodology can be applied to all processes and to the quality management system as a whole. It also states that the ISO 9001 clauses broadly follow the PDCA cycle as summarized below: Plan: establish objectives and resources Do: implement what was planned Check: monitor, measure, and report results Act: take actions to improve process performance A...

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ISO/DIS 9001:2015, Clause 0.5

Oct 1, 2014 in Newsletter | Comments Off on ISO/DIS 9001:2015, Clause 0.5

Clause 0.5 of the Introduction section of the draft ISO 9001:2015 standard states that risk is the “effect of uncertainty on an expected result”, and that the concept of risk-based thinking has always been implicit in ISO 9001. As background information, an “effect” is a deviation from the expected, and can be positive or negative. The term “uncertainty” is the state, even partial, of a deficiency of information related to the understanding or knowledge of an event, its consequence, or likelihood. Risk is...

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Free ISO/DIS 14001

Sep 1, 2014 in Newsletter | Comments Off on Free ISO/DIS 14001

The American Society for Quality (ASQ) is providing a free copy of the Draft International Standard (DIS) version of ISO 14001:2015 for review and comment. Send an email to standards@asq.org to request a review copy. Your comments must be submitted by October 19, 2014. Note that ISO/DIS 14001 is being provided for the purpose of review and comment related to the preparation of the U.S. position. All other rights are reserved. Please note that the ISO/DIS 14001 is not final and should not be used for making changes to existing environmental...

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ISO 9001:2015

Sep 1, 2014 in Newsletter | Comments Off on ISO 9001:2015

Certification bodies have information to share on the ISO 9001:2015 revision. I have identified links provided at the web sites of two of our business partners: National Quality Assurance (NQA) See these web pages at the NQA web site for information on the ISO 9001:2015 revision: ISO 9001:2015 Revision Information ISO 9001:2015 Slide Presentation (36 slides) British Standards Institution (BSI) See these web pages at the BSI web site for information on the ISO 9001:2015 revision: ISO 9001:2015 Revision Information Two Videos on ISO 9001:2015...

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Service PPAP

Sep 1, 2014 in Newsletter | Comments Off on Service PPAP

Developed to address the specific requirements of service part production, the new AIAG Service Production Part Approval Process (Service PPAP) is a supplement to the Production Part Approval Process (PPAP) 4th edition. Service PPAP identifies requirements and provides clarification for the PPAP process for service unique parts, including remanufactured parts, service unique chemicals, third party packagers, and service software requirements. Service PPAP is intended to provide evidence that all customer engineering design record and...

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Most Dangerous Jobs

Sep 1, 2014 in Newsletter | Comments Off on Most Dangerous Jobs

According to the Census of Fatal Occupational Injuries published by the Bureau of Labor Statistics, 3 employees out of every 100,000 are killed annually in a work-related incident in the United States. These 10 jobs have a significantly higher fatality rate than the national average: 1. Loggers Loggers experienced 62 fatalities in 2012 for a fatality rate of 127.8 out of 100,000 workers, making it the most dangerous profession. Risks: Falls, struck-by, dangerous tools such as chainsaws and axes. 2. Fishermen Fishermen and women experienced 117...

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ASQ Fall Conference

Sep 1, 2014 in Newsletter | Comments Off on ASQ Fall Conference

Register for the ASQ Technical Communities Fall Conference in Orlando: October 27 – 29, 2014 – Preconference Tutorials October 29, 2014 – Opening Reception October 30 – 31, 2014 – Conference The Technical Communities Fall Conference has a full slate of exciting keynotes, tutorials, workshops, and speakers.  Larry Whittington will speak Friday morning on Auditing: Prepare Well to Perform Well. Registration is available at the conference website. The conference will be held at the Wyndham Orlando Resort, 8001...

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ISO/DIS 9000, Terms

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, Terms

The terms defined in ISO 9000:2005 were grouped into 10 categories: quality, management, organization, process and product, characteristics, conformity, documentation, examination, audit and measurement processes. The draft ISO 9000:2015, Quality management systems – Fundamentals and vocabulary, has expanded the defined terms by nearly 75% and has revised the term categories as shown below: 3.1 Terms related to person or people 3.2 Terms related to organization 3.3 Terms related to activity 3.4 Terms related to system 3.5 Terms related...

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ISO/DIS 9000, Index

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, Index

The following terms are defined in ISO/DIS 9000:2015, Quality management systems – Fundamentals and vocabulary. All the terms defined in ISO 9000:2005 have been retained in the draft standard except for “qualification process”. The 61 added terms are shown in bold. activity association audit audit client audit conclusion audit criteria audit findings audit plan audit program audit scope audit team auditee auditor capability change control characteristic combined audit competence competence...

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ISO/DIS 9000, QMPs

Aug 1, 2014 in Newsletter | Comments Off on ISO/DIS 9000, QMPs

The draft version of ISO 9000:2015, Quality management systems – Fundamentals and Vocabulary, has expanded coverage of the quality management principles. The 8 quality management principles of ISO 9000:2005 are each described by a single sentence in the Introduction section of that standard. The 7 quality management principles in ISO/DIS 9000:2015 have been placed in a more prominent location in section 2, Quality management principles and fundamental concepts. Quality management principles 1. Customer focus 2. Leadership 3. Engagement...

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Use of AS9101E

Aug 1, 2014 in Newsletter | Comments Off on Use of AS9101E

The International Aerospace Quality Group (IAQG) has posted Resolution 117 to its IAQG OPMT ICOP Resolutions Log. The resolution states that Certification Bodies (CBs) must implement the AS9101E / 9101:2014 audit requirements standard no later than July 01, 2015. This timeline may be accelerated and implementation can occur upon completion of the following: CB procedures and processes must be updated to address conformance to the requirements of the revised standard, including access to approved 9101 Forms on the IAQG Forms Management System...

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ISO 9001:2015, 6.1

Aug 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 6.1

Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. According to the draft ISO 9001:2015 standard, management of these processes and the system as a whole can be achieved using a “Plan-Do-Check-Act” (PDCA) methodology, with an overall focus on “risk-based thinking” aimed at preventing undesirable outcomes. Risk-based Thinking Section 0.5 in ISO/DIS 9001:2015 states that risk is the...

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Complaints Handling

Aug 1, 2014 in Newsletter | Comments Off on Complaints Handling

The ISO 10002 standard on complaints handling has been revised. ISO 10002:2014, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations, is available at this ANSI e-Standards Store web page. ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The described complaints handling process is suitable for use as one of the processes of an overall quality management...

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Free ISO/DIS 9001

Jul 1, 2014 in Newsletter | Comments Off on Free ISO/DIS 9001

The American Society for Quality (ASQ) is providing the Draft International Standard (DIS) version of ISO 9001:2015 free to anyone, with the condition that you review it and provide comments to prepare the U.S. position. Send an email to standards@asq.org to request a copy for review. Your comments must be submitted before July 15, 2014. According to ASQ, the timeline for ISO 9001:2015 is: Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of the International Standard as ISO 9001:2015 Please...

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ISO 13485 Revision

Jul 1, 2014 in Newsletter | Comments Off on ISO 13485 Revision

ISO/DIS 13485:201X, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was published in February 2014.  The five month voting period for comments to be submitted by the National Standards Bodies to the ISO Central Secretariat will close in July 2014. The DIS comments will be reviewed at a September 2014 meeting of the ISO/TC 210 Working Group 1. The Final Draft International Standard (FDIS) version should be issued for a two month vote late in 4Q/2014. Assuming the FDIS is approved,...

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ISO 9001:2015, 9.1.1

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.1

This article provides a summary of the General requirements section of Monitoring, Measurement, Analysis, and Evaluation as stated in the Draft International Standard (DIS) version of ISO 9001:2015. The changes from the related ISO 9001:2008 requirements are also identified. ISO/DIS 9001:2015 Summary 9.1.1 General Determine: what needs to be monitored and measured the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results when the monitoring and measuring will be performed when the results from...

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ISO 9001:2015, 9.1.2

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.2

This article provides a summary of the Customer Satisfaction requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS customer satisfaction differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.2 Customer Satisfaction Monitor customer perceptions of degree to which requirements have been met Obtain information on customer views and opinions of the organization and its products and services Determine methods for obtaining and using this...

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ISO 9001:2015, 9.1.3

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.3

This article provides a summary of the Analysis and Evaluation requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The draft analysis and evaluation differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.3 Analysis and Evaluation Analyze and evaluate appropriate data and information arising from monitoring, measurement, and other sources. Use the output of this analysis and evaluation to: demonstrate conformity of products and services to...

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EHSQ Manager Job

Jul 1, 2014 in Newsletter | Comments Off on EHSQ Manager Job

A client is looking for a Manager of EHSQ Management Systems, located in Atlanta, GA.  Please see the job description below, and if you are qualified and interested, contact David DiBoyan, Director of Americas EHSQ, at David.DiBoyan@Kemira.com. Position Summary: This position is responsible for managing the integrated safety, quality, and environmental management systems registered in Kemira’s Americas region.  This is a regional position interfacing with all functional departments, including sales, manufacturing, and logistics, with...

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ISO 9001:2015, Clause 9.3

Jun 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, Clause 9.3

This article provides a summary of the Management Review requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS Management Review differences from ISO 9001:2008 are also described. ISO/DIS 9001:2015 Summary 9.3 Management Review 9.3.1 Review the quality management system at planned intervals to ensure a suitable, adequate, and effective system. Plan and carry out management review considering: Status of actions from previous management reviews Changes in external and internal...

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ISO 9001:2015, Clause 9.2

Jun 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, Clause 9.2

This article provides a summary of the Internal Audit requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS internal audit differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary 9.2 Internal Audit 9.2.1 Conduct internal audits at planned intervals to provide information on whether the quality management system: Conforms to the organization’s own requirements Conforms to the requirements of ISO 9001 Is effectively implemented and maintained 9.2.2 The...

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Standard for Cities

Jun 1, 2014 in Newsletter | Comments Off on Standard for Cities

  A landmark ISO standard outlining key measurements for evaluating a city’s service delivery and quality of life has been published as ISO 37120:2014, “Sustainable development of communities – Indicators for city services and quality of life”. Its use will help city managers, politicians, researchers, business leaders, planners, designers, and other professionals to focus on key issues, and put in place policies for more livable, tolerant, sustainable, resilient, economically attractive, and prosperous cities. Why...

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Publicize Certification

Jun 1, 2014 in Newsletter | Comments Off on Publicize Certification

You are proud of achieving your management system certification and want to communicate your success to the marketplace. And, publicizing your certification may attract additional business. However, be careful how you promote your certification to avoid the pitfalls of false, misleading, or confusing statements. You may end up harming the credibility of your organization. The International Organization for Standardization (ISO) has issued guidelines on how to correctly publicize your certification. You should follow these guidelines with the...

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Guiding Principles

May 1, 2014 in Newsletter | Comments Off on Guiding Principles

The world’s largest automakers have reached an agreement on their corporate responsibility expectations for suppliers regarding human rights, environment, working conductions, and business ethics. Participating members of AIAG and CSR Europe that reached this agreement include BMW, Chrysler, Daimler, Fiat, Ford, GM, Honda, Jaguar/Land Rover, Peugeot, Scania, Toyota, VW, and Volvo. The agreement is shown below. Guiding Principles We endeavor to achieve excellence, innovation and performance in a sustainable manner. People and the...

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Data Breaches

May 1, 2014 in Newsletter | Comments Off on Data Breaches

Last year a lot of attention was focused on cyber-espionage, threats to privacy, and the acts of malicious insiders. Events at the end of 2013 provided a painful reminder that cybercrime remains prevalent and that damaging threats from cybercriminals continue to loom over businesses and consumers. Eight breaches in 2013 each exposed more than 10 million identities. Targeted attacks increased and end-user attitudes towards social media and mobile devices resulted in wild scams. Symantec’s 2014 Internet Security Threat Report covers a wide...

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Auditor Certification

May 1, 2014 in Newsletter | Comments Off on Auditor Certification

Some students that complete Internal Auditor or Lead Auditor training mistakenly consider themselves to be certified auditors. They may be qualified based on that training to conduct audits for their company, but there are additional steps to become an Exemplar Global (was RABQSA) certified auditor. Perhaps the confusion is that they receive a course certificate after the class. While that is evidence of their auditor training for organizational reasons, the certificate is just proof they have met the training prerequisite for Exemplar Global...

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ISO/TR 18128:2014

May 1, 2014 in Newsletter | Comments Off on ISO/TR 18128:2014

Companies spend a tremendous amount of time and money managing business records to control their activities, improve their operations, and demonstrate compliance with the law. But what happens when these records are misfiled, damaged, or deleted? ISO/TR 18128:2014, Information and documentation — Risk assessment for records processes and systems, will help organizations assess risks to their records processes and systems so they can ensure records continue to meet their business needs for as long as required. The consequence of risk...

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ISO 45001 for OH&S

Apr 1, 2014 in Newsletter | Comments Off on ISO 45001 for OH&S

We announced in an October 2013 newsletter article that ISO is developing a standard for Occupational Health and Safety (OH&S) to replace the BSI standard OHSAS 18001:2007. The new ISO standard will be known as ISO 45001 and is expected to be published in 2016. The proposed schedule for the development and publication of ISO 45001 is: ISO/CD 45001 (Committee Draft) – May 2014 ISO/DIS 45001 (Draft International Standard) – February 2015 ISO/FDIS 45001 (Final Draft International Standard) – March 2016 ISO 45001 to be...

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Quality in the Public Sector

Apr 1, 2014 in Newsletter | Comments Off on Quality in the Public Sector

How can government increase efficiency, prevent errors, and improve customer service? Two new public sector standards using ISO 9001:2008 could be the answer. ISO 18091 provides guidance for local government and ISO/TS 17582 is available for electoral bodies. ISO 18091:2014, Quality management systems – Guidelines for the application of ISO 9001:2008 in local government The objective of ISO 18091 is to provide local governments with guidelines for achieving reliable results through the application of ISO 9001:2008 on an integral basis....

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Auditee Tactics

Apr 1, 2014 in Newsletter | Comments Off on Auditee Tactics

The reactions of interviewed people may range from full cooperation to rare cases of outright hostility. Negative responses may be due to negative management attitudes and the way the audit was announced. Attitudes are contagious. It could also be due to a lack of audit experience and the fear of the unknown. The word “audit” does have a negative connotation. If people believe audits make people look bad, trigger punitive actions, and cause extra work – guess what – they may try to delay your appointed audit rounds to...

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Auditee Responsibility

Apr 1, 2014 in Newsletter | Comments Off on Auditee Responsibility

Auditors are trained on their audit responsibilities, but do the managers of the areas to be audited understand their audit responsibilities? Audit Objectives The objectives of an audit are to determine conformity to the audit criteria, evaluate the capability to meet customer needs, ensure compliance with legal requirements, and determine the effectiveness of the management system. In addition, the audit may identify opportunities for improvement, reduce the risk of product and service failures, and increase the awareness of the...

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Cybersecurity

Mar 1, 2014 in Newsletter | Comments Off on Cybersecurity

The National Institute of Standards and Technology (NIST) recently issued a 40 page document titled, “Framework for Improving Critical Infrastructure Cybersecurity”. It states that the national and economic security of the United States depends on the reliable functioning of critical infrastructure. Cybersecurity threats exploit the increased complexity and connectivity of critical infrastructure systems, placing the nation’s security, economy, and public safety and health at risk. Similar to financial and reputational risk,...

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ISO 14001:2015

Mar 1, 2014 in Newsletter | Comments Off on ISO 14001:2015

ISO 14001:2004, the environmental management system standard, is being revised. The updated third edition is expected in early 2015. The Committee Draft (CD) of ISO 14001:2015 was issued in October 2013. The plan is to review the CD comments, revise the text, and issue a Draft International Standard (DIS) in mid-2014. An article in issue 44 of IRCA’s INform e-magazine identified these emerging ISO 14001 changes: Leadership – to ensure the success of the system, a new clause has been added that assigns specific responsibilities to...

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ISO/TS 16949 Rules

Mar 1, 2014 in Newsletter | Comments Off on ISO/TS 16949 Rules

The latest revision of the rules for achieving and maintaining International Automotive Task Force (IATF) recognition were released by the IATF on October 1, 2013 and will come into effect April 2014 with a full transition to be completed by April 2015. 2013 IATF Global Certification Body (CB) conference CB’s were given the opportunity to hear directly from IATF members the rational of the new rules, explanations of change, and ongoing requirements of the scheme including the changes expected as a result of the 9001:2015 revision. The...

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Electronic Manifests

Mar 1, 2014 in Newsletter | Comments Off on Electronic Manifests

      The Environmental Protection Agency (EPA) has issued a final rule that authorizes the use of electronic manifests to track hazardous waste. The e-Manifest system will track off-site shipments of hazardous waste from a generator’s site to the site of the receipt and disposition of the hazardous waste. The final rule implements provisions of the Hazardous Waste Electronic Manifest Establishment Act, which directs the EPA to establish a national e-Manifest system, and to impose reasonable user service fees as a means...

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Auditor Behavior

Feb 2, 2014 in Newsletter | Comments Off on Auditor Behavior

Confidence in the audit process and its ability to achieve the audit objectives depends on the competence of the individuals who are involved in planning and conducting audits, including auditors and audit team leaders. All auditors should possess generic knowledge and skills, and should also be expected to possess some discipline and sector-specific knowledge and skills. Audit team leaders should have the additional knowledge and skills necessary to lead the audit team. According to clause 7.2.2 of ISO 19011:2011, auditors should also possess...

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Audit Principles

Feb 2, 2014 in Newsletter | Comments Off on Audit Principles

Auditing relies upon a set of principles to help make an audit an effective and reliable tool in support of management policies and controls. Audits provide information for organizations to act on to improve their business performance. According to ISO 19011:2011, audits should be based on these six principles: 1. Integrity: foundation of professionalism. 2. Fair presentation: obligation to report truthfully and accurately. 3. Due professional care: application of diligence and judgment in auditing. 4. Confidentiality: security of...

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Audit Findings

Feb 2, 2014 in Newsletter | Comments Off on Audit Findings

Auditors evaluate audit evidence against audit criteria to determine audit findings. These audit findings can indicate conformity or nonconformity with the audit criteria. Nonconformities and their supporting audit evidence should be recorded. Nonconformities may be graded in terms of severity, e.g. minor or major, for prioritizing corrective actions. Review nonconformities with the audited area to obtain acknowledgement that the audit evidence is accurate and the nonconformities are understood. Attempt to resolve any diverging opinions...

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Cyber Warfare

Feb 2, 2014 in Newsletter | Comments Off on Cyber Warfare

Cyber threats continue to plague governments and businesses around the world. These threats are on the rise as cyber criminals increase their focus and know-how. The problem demands an international solution. ISO 27001 provides a management framework for assessing and treating risks (whether cyber-oriented or otherwise) that can damage business, governments, and even a national infrastructure. Information security incidents are on the rise as cyber criminals increase their focus on both large and small businesses. The 2013 Information Security...

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ASQ Quality Research

Jan 1, 2014 in Newsletter | Comments Off on ASQ Quality Research

For the past year, the American Society for Quality (ASQ) has developed, gathered, and analyzed survey results, data, information, and personal interviews from organizations in more than 22 countries. This effort has culminated in the seven reports described below. According to ASQ, each report is packed with valuable information for any organization. All the reports are free to ASQ members. Non-members can receive two of the reports for free. They must pay $29 to $49 for each of the remaining five reports. ASQ Global State of Quality...

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Measurements Course

Jan 1, 2014 in Newsletter | Comments Off on Measurements Course

We have published articles on performance measurements. You can see a partial list at the end of this article. We are now pleased to offer a new 2-day course, “Measuring Process and Organizational Performance”. Course Description: A key aspect of organizational performance management is selecting, defining, collecting data on, monitoring, and responding to performance metrics. However, it is important that the right ones be selected, tracked, and responded to. This workshop will present a process for selecting what to measure, how...

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Papers on Auditing

Jan 1, 2014 in Newsletter | Comments Off on Papers on Auditing

The ISO 9001 Auditing Practices Group is an informal group of quality management system experts, auditors, and practitioners drawn from the ISO Technical Committee 176 and the International Accreditation Forum. It has developed a number of brief guidance papers that contain explanations about the auditing of quality management systems. These papers reflect the process-based approach that is essential for auditing the requirements of ISO 9001. The International Register of Certificated Auditors (IRCA) has selected some of these audit guidance...

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ISO Certificate Survey

Jan 1, 2014 in Newsletter | Comments Off on ISO Certificate Survey

ISO has released the results of its annual survey of certifications. The summary below shows the number of worldwide certificates issued for seven of the management system standards, along with the USA totals. ISO 9001 (Quality) Certificates in 2012 = 1,101,272 (USA = 26,177) Certificates in 2011 = 1,079,647 (USA = 25,811) Increase = +21,625 (USA = +366) Percentage = +2% (USA = +1%) ISO 14001 (Environment) Certificates in 2012 = 285,844 (USA = 5,699) Certificates in 2011 = 261,957 (USA = 4,957) Increase = +23,887 (USA = +742) Percentage =...

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ISO 9001:2015 Survey

Jan 1, 2014 in Newsletter | Comments Off on ISO 9001:2015 Survey

The Chartered Quality Institute (CQI) conducted a survey of its members on the Committee Draft of ISO 9001:2015. This major revision of ISO 9001 is planned for publication in late 2015, and is expected to significantly impact certification bodies, training firms, and certified businesses, and of course, auditors. The CQI survey was conducted to determine which elements their members liked, viewed as a cause for concern, and those with which they disagreed. The INform magazine summarized the more than 1,400 responses into the following...

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TL 9000 R5.5 Requirements Handbook

Dec 1, 2013 in Newsletter | Comments Off on TL 9000 R5.5 Requirements Handbook

The new TL 9000 R5.5 Requirements Handbook may be used for audits conducted on or after January 1, 2014. It must be used for audits conducted on or after January 1, 2015, meaning the R5.0 Requirements Handbook can be used until January 1, 2015. Adder Changes There are two new or split adders in R5.5 (an adder is a unique TL 9000 requirement beyond those included from ISO 9001). Four adders have a changed scope. Seven adders were modified and two adders were deleted.  Four adder clauses were renumbered and seven adders were reworded for...

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Document Reviews

Dec 1, 2013 in Newsletter | Comments Off on Document Reviews

Documents are reviewed before an audit and during an audit. The relevant documents are reviewed before an audit to: Gather information to plan your audit activities and develop work documents Examine the extent of the documentation to detect possible gaps Documents, records, and prior audit reports are included in this review. Auditors should consider the size, nature, and complexity of the organization and system, as well as, the audit objectives and scope. During the audit, the applicable documents are reviewed to: Determine conformity of...

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Certification Scope

Dec 1, 2013 in Newsletter | Comments Off on Certification Scope

The scope of a quality management system defines its geographic locations, product lines (including services), applicable processes, and identifies any excluded ISO 9001 requirements. Sites For example, an organization can define its scope to include a single site, or the scope can include multiple sites if they have a common system and the same top management. Products The scope can include the applicable processes for a single product or service, or include the processes necessary for multiple products and services. Processes The scope...

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Process Owner Duties

Dec 1, 2013 in Newsletter | Comments Off on Process Owner Duties

Some process owners have specific requirements in ISO 9001 that apply to their process, e.g., clause 7.4 provides unique requirements for the purchasing process. However, there are some general ISO 9001 requirements that apply to all processes within the quality management system. Clause 4.2.3 describes document control requirements for all types of process documents, e.g., procedures, instructions, and forms. Clause 4.2.4 describes record control requirements for all types of process records, e.g., those that provide evidence of conformity to...

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Manufacturing Metrics

Dec 1, 2013 in Newsletter | Comments Off on Manufacturing Metrics

Mark Davidson recently posted a blog entry titled, “28 Manufacturing Metrics that Actually Matter (The Ones We Rely On)” at the LNS Research web site. He notes that the Manufacturing Enterprise Solutions Association (MESA) has sponsored research to help the manufacturing marketplace identify the most important metrics, and help decision makers understand metrics improvements and their relationships to metrics programs and the use of software solutions. As part of the most recent metrics survey, 28 manufacturing metrics were...

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3-D Printing

Nov 1, 2013 in Newsletter | Comments Off on 3-D Printing

According to an Industry Week article, additive manufacturing could make our complicated global supply chain obsolete within the next decade, replacing it with a new economy based on a high-tech system of local, connected suppliers. Additive manufacturing techniques like select laser sintering (SLS) can build complex 3-D parts directly from powdered metal, turning globally distributed production efforts into in-house jobs. Note: SLS involves the use of a high power laser to fuse small particles of plastic, metal, ceramic, or glass powders into...

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Webinar on Audit Interviews

Nov 1, 2013 in Newsletter | Comments Off on Webinar on Audit Interviews

Larry Whittington will present a one hour “Audit Interviews” webinar at 1:00 PM ET on Wednesday, November 20, 2013. He recently presented this session at the 2013 ASQ Audit Conference in Tucson, AZ. You can register for the webinar at this web page. Webinar Description Audit interviews are one of four ways to gather information during an audit, the others being to review documents, observe operations, and examine records. Conducting efficient and effective interviews will be the key to a successful audit. During interviews, we...

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ISO 9001:2015 Highway: The Revolution

Nov 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Highway: The Revolution

J.P. Russell provided a handout at the 2013 ASQ Audit Conference titled the “ISO 9001:2015 Highway: The Revolution”. With his permission, I am reproducing the handout for our newsletter readers: There are major events taking place in the standards community that may change the ISO 9001 worldwide community forever.  It is as if we have all been traveling down this super highway and suddenly signs popped up indicating that the road ahead has changed. So, now we will need to assess the situation and make some decisions on how we are...

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Free OSHA Consulting

Nov 1, 2013 in Newsletter | Comments Off on Free OSHA Consulting

The Occupational Safety and Health Administration (OSHA) has an On-site Consultation Program that offers free and confidential advice to small and medium-sized businesses in every state, with priority given to high-hazard worksites. In the past fiscal year, the On-site Consultation Program conducted about 30,000 visits to small business worksites covering over 1.5 million workers across the nation. The On-site Consultation services are separate from enforcement and do not result in penalties or citations. The program is state-run but federally...

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Insider Data Thieves

Oct 1, 2013 in Newsletter | Comments Off on Insider Data Thieves

The highly networked computer technology that has made companies more efficient has also left them more vulnerable to threats from insiders that are intent on stealing information or sabotaging operations. And, those vulnerabilities are regularly exploited. According to a recent Wall Street Journal article by Siobhan Gorman, there are procedures and technologies that can help defend a company against malicious insiders. This newsletter article summarizes her article on “How to Stop the In-House Data Thief”. Access...

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Revised Quality Management Principles

Oct 1, 2013 in Newsletter | Comments Off on Revised Quality Management Principles

The ISO 9001:2008 standard states that the eight quality management principles described in ISO 9000:2005 were considered during the development of ISO 9001:2008. According to the committee draft of ISO 9001:2015, the revised standard is being developed to make more explicit use of the quality management principles. ISO 9001:2015 includes an Annex A that introduces the seven quality management principles upon which the revised standard is based. The annex provides a “statement” describing each principle and a...

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New ISO 9001:2015 Definitions

Oct 1, 2013 in Newsletter | Comments Off on New ISO 9001:2015 Definitions

The committee draft of ISO 9001:2015 includes terms from Annex SL that are to be used for all new or revised management system standards. They were included in the draft ISO 9001 standard to assist its reviewers.  There is no agreement to keep these terms in ISO 9001. They will likely be moved to the ISO 9000 Fundamentals and Vocabulary standard. Unchanged Definitions Some of the ISO 9001:2015 definitions match those in the current ISO 9000: Requirement, Top Management, Effectiveness, Process, Audit, Conformity, Nonconformity, and...

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New ISO Health and Safety Standard

Oct 1, 2013 in Newsletter | Comments Off on New ISO Health and Safety Standard

ISO has approved the creation of a new project committee to develop an International Standard for Occupational Health and Safety (OH&S). The much-awaited standard will provide governmental agencies, industry, and other affected stakeholders with effective, usable guidance for improving worker safety. The work will be overseen by ISO Project Committee (PC) 283, Occupational health and safety management systems – Requirements. According to International Labor Organization (ILO) statistics, 6300 people die every day due to occupational...

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ISO 9001:2015 Documented Information

Sep 1, 2013 in Newsletter | Comments Off on ISO 9001:2015 Documented Information

In ISO 9001:2008, clause 4.2.1 identifies the required documents for a quality management system as the quality policy, quality objectives, quality manual, and the procedures required by the standard. The required documented procedures are identified in later clauses as 4.2.3 (Control of Documents), 4.2.4 (Control of Records, 8.2.2 (internal Audit), 8.3 (Control of Nonconforming Product), 8.5.2 (Corrective Action), and 8.5.3 (Preventive Action). The Committee Draft of ISO 9001:2015 makes use of the term “documented information” to...

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